A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients

Alcon

Status and phase

Completed

Phase 4

Conditions

Moderate to Severe Dry Eye

Treatments

Other: Systane

Study type

Interventional

Funder types

Industry

Identifiers

NCT01311609

C-11-005

Details and patient eligibility

About

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

Full description

This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older, of both sexes, and any race.
Willing and able to make all required visits and follow study instructions.
A sodium fluorescein corneal staining sum of >/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart

Exclusion criteria

A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
Lasik patients can be included if Lasik surgery was > 6 months prior to the initiation of the study.
A history of intolerance or hypersensitivity to any component of the study medications.